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A Study of RoActemra/Actemra (Tocilizumab) Plus DMARDs in Patients With Rheumatoid Arthritis

NCT ID: NCT01214733

Last Updated: 2015-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2011-05-31

Brief Summary

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This open-label study will evaluate the long-term safety and efficacy of RoActemra/Actemra (tocilizumab) in combination with disease modifying anti-rheumatic drugs (DMARDs) in patients with moderate to severe rheumatoid arthritis. Patients who successfully completed studies WA17823 and WA18696 in South Africa are eligible to participate in this study. Patients will be allowed DMARDs according to the treatment they received in the previous studies. Patients will receive 8 mg/kg RoActemra/Actemra intravenously every 4 weeks. The anticipated time on study treatment is 104 weeks.

Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type EXPERIMENTAL

tocilizumab [RoActemra/Actemra]

Intervention Type DRUG

8 mg/kg intravenously every 4 weeks in combination with allowed DMARDs

Interventions

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tocilizumab [RoActemra/Actemra]

8 mg/kg intravenously every 4 weeks in combination with allowed DMARDs

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adult patients, \>/=18 years of age
* Moderate to severe rheumatoid arthritis of more than 6 months duration upon entering the study
* Patients successfully completed studies WA17823 and WA18696 in South Africa
* Body weight \<150 kg

Exclusion Criteria

* Patients who have withdrawn from studies WA17823 and WA18696 are not eligible to participate in this study Treatment with any investigational agent since last administration of study drug in studies WA17823 and WA18696
* Previous treatment with any cell depleting therapies
* Treatment with intravenous gamma globulin, plasmapheresis or Prosorba(TM) column since the last administration of study drug in studies WA17823 and WA18696
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Cape Town, , South Africa

Site Status

Cape Town, , South Africa

Site Status

Cape Town, , South Africa

Site Status

Diepkloof, , South Africa

Site Status

Countries

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South Africa

Other Identifiers

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ML25321

Identifier Type: -

Identifier Source: org_study_id